Anti-Extravasation Surgical Portal Plug

ABSTRACT

The devices and methods shown provide for the minimization of extravasation during arthroscopic surgery. The anti-extravasation surgical portal plug allows a surgeon to drain excess fluids from the soft tissue surrounding the surgical field during arthroscopic surgical procedures.

This application is a continuation of U.S. application Ser. No.14/183,178 filed Feb. 18, 2014, now U.S. Pat. No. 9,211,139 which is acontinuation of U.S. application Ser. No. 11/437,148 filed May 18, 2006,now U.S. Pat. No. 8,652,090.

FIELD OF THE INVENTIONS

The inventions described below relates to the field arthroscopic surgeryand more specifically, to fluid management during arthroscopic shouldersurgery.

BACKGROUND OF THE INVENTIONS

During minimally invasive surgeries, surgical instruments such astrocars, cannulas, and optical medical devices, including endoscopes,cystoscopes, arthroscopes, laparoscopes, etc., are inserted throughsmall incisions or surgical portals in a patient's body or body cavityand manipulated to perform surgical procedures within the patient.

Minimally invasive surgical procedures are safer than open surgery andresult in quicker patient recovery, shorter hospital stays, and lowerhealth care costs. Accordingly, minimizing invasiveness continues to beof importance, and there is a continuing need for devices and methodsthat achieve this objective.

Areas that have benefited from minimally invasive surgical techniquesinclude shoulder and knee surgery. Shoulder and knee surgery haveevolved over the last several years from being open surgical proceduresto arthroscopic surgical procedures. This evolution is the result oftechnological advances in equipment, instruments and implants.

During surgery, surgical portals are made into the patient to facilitatesurgery and fluid is introduced into the surgical site to expand thejoint and control bleeding. One concern involving arthroscopic surgeryincludes fluid leaking out of open unused surgical portals when surgicalinstruments are removed. Open portals tend to leak irrigation fluidwhich gets on the surgery room floor and the surgeon himself. Anotherconcern involving arthroscopic surgery includes extravasation.Extravasation is the collection of interstitial fluid such as blood,irrigation fluids or medications into tissue surrounding an infusionsite. Fluid escaping into the soft tissues of the shoulder and theperiscapular region can have adverse effects on the patient. Some ofthese effects include tracheal compression, the accumulation of blood orclots in the joint (hemarthrosis), the forming of blood clots in veins(thrombophlebitis), arterial injury, nerve injury, the compression ofblood vessels and nerves surrounding the joint (compartment syndrome),and infection. These effects cause longer recovery time as well as painand discomfort in patients. Extravasation occurring during surgery canalso cause premature collapse of the surgical field forcing surgeons torush procedures.

Another concern during the performance of surgical procedures is thetendency of surgical instruments to be easily pushed out or removed fromsurgical portals. Many retention devices have been used to prevent theeasy removal of devices during surgery. These devices and methods,however, can cause additional damage and trauma to tissue surroundingthe surgical portal. Present tissue retention systems use a series ofpointed ridges or threads disposed on the surface of arthroscopicsurgical instrument to prevent the instruments from being easily removedfrom a surgical portal once they are disposed in the surgical portal.

Because of fluid leakage and the effects caused by extravasation and thetrauma caused by traditional retention systems, devices and methods areneeded to temporarily close unused surgical portals, reduceextravasation during arthroscopic surgery reduce and the traumapotentially caused by retention systems.

SUMMARY

The devices and methods shown below provide for the minimization offluid leakage and extravasation during arthroscopic surgery. The portalplug allows a surgeon to temporarily close a surgical portal whiledraining fluids from the soft tissue surrounding the surgical field.

The portal plug is a multi-lumen tube or sheath disposed about an innercore. The proximal portion of the sheath is provided with a handle orgrip and a drainage port. The body or central portion of the sheath isprovided with a plurality of drainage apertures. Each drainage aperturecommunicates with one or more of the drainage lumens inside the sheath,thereby allowing fluid to drain from the tissue surrounding the surgicalsite to sources or sinks located outside the patient. The portal plugallows the surgeon to temporarily close a surgical portal while reducingthe amount of fluid extravasation occurring in surrounding tissue. Theouter surface of the central portion of the sheath of the portal plugmay be embossed with a plurality of cup-shaped depressions, concavepockets or ridges that compose the retention system. When theanti-extravasation sheath is in use, a partial vacuum is produced whentissue surrounding a surgical portal comes in contact with the retentionsystem disposed on the outer surface of the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a method of performing arthroscopic surgery on apatient using an anti-extravasation surgical portal plug.

FIG. 2 illustrates an exploded view of the anti-extravasation surgicalportal plug.

FIG. 3 illustrates a longitudinal sectional view of theanti-extravasation surgical portal plug sheath.

FIG. 4 illustrates the inner core for use in the anti-extravasationsurgical portal plug.

FIG. 5 shows a radial cross-sectional view of the anti-extravasationsurgical portal plug using the inner surface of the sheath wall with theouter surface of the inner core to form drainage lumens.

FIG. 6 shows the inner core rotated within the sheath.

FIG. 7 illustrates the sheath with an alternative control system.

FIG. 8 shows the sheath having a membrane valve disposed in its distalend.

FIG. 9 illustrates an alternative embodiment of an anti-extravasationsurgical portal plug.

FIG. 10 illustrates a longitudinal cross-section of the alternativeembodiment of the anti-extravasation surgical portal plug.

FIG. 11 illustrates an anti-extravasation surgical portal plug having asheath with a retention system.

DETAILED DESCRIPTION OF THE INVENTIONS

FIG. 1 illustrates a method of performing arthroscopic surgery on apatient's shoulder 1 using the anti-extravasation surgical portal plug2. The portal plug 2 is shown inserted into a surgical portal 3 orincision providing access to the joint capsule 4 of a shoulder of apatient. Various anatomical landmarks are depicted including thepatient's clavicle 5, scapula 6 and humerus 7.

During arthroscopic shoulder surgery, the surgeon introduces thearthroscope into the shoulder via a first portal in order to visualizethe surgical field. A trimming instrument is introduced through a secondportal to remove or trim tissue that the surgeon determines should beremoved or trimmed. Optionally, an irrigating instrument may beintroduced through a third portal in order to distend the joint, and/orirrigate the surgical field to maintain a clear view. Other arthroscopicinstruments used in arthroscopic surgery include endoscopes, awls, picksor shavers. When a surgical instrument is removed from a portal, theportal plug may then be inserted into the surgical portal to preventfluid leakage and prevent extravasation.

FIG. 2 illustrates an exploded view of surgical portal plug 2 while FIG.3 illustrates a longitudinal sectional view of a portal plug sheath. Theanti-extravasation surgical portal plug comprises a close-ended sheath 8or tube disposed about an inner core 9. The sheath 8 is a tube ofresilient material such as nylon, polycarbonate urethane, polyurethane,polydimethylsiloxane and polyethylene glycol or rubber, characterized bya central lumen 10 and closed at its distal end 11. The inner diameter12 of the sheath is sized and dimensioned to closely fit over the outerdiameter 13 of the inner core 9. The sheath is characterized by a distalportion 14, a central portion 15 and a proximal portion 16. A hub 17 orgrip is disposed on the proximal section of the sheath and may beintegrally formed with the sheath. The proximal portion 16 of the sheathfurther comprises a radial flange 18. The flange 18 can be provided withan adhesive layer 19 or surface on its distal bottom surface to assistwith holding the sheath in the wound. The flange 18 prevents the plugfrom entering too deep into the surgical portal. A drainage port 20 influid communication with the central lumen 10 is disposed on theproximal section and may be operably coupled to a vacuum source or sink.A proximal section opening is provided in the sheath so the inner coremay be inserted. The body or central portion 15 of the sheath contains aplurality of drainage apertures 21. The apertures 21 may be disposed ina series of linear arrays. Each drainage aperture communicates with oneor more of the drainage lumens inside the sheath. The drainage apertures21 are disposed in such a way that they are placed in fluidcommunication with tissue surrounding a joint capsule or surgical fieldwhen the plug is in use. The drainage apertures 21 communicate with oneor more drainage lumens 33 disposed inside the plug which allows fluidto drain from the tissue surrounding the capsule to vacuum sources orsinks located outside the patient through the drainage port. Thedrainage port 20 can be adapted for coupling to an active or passivevacuum source or sink. The outer surface of the proximal section of theplug is corrugated or provided with ridges 22 to prevent the sheath orinstrument from being unintentionally forced out of the operating field.The ridges 22 of the tissue retention feature are circumferentiallydisposed around the portal plug 2 and may be in the shape of straightridges extending radially outward as illustrated in FIG. 2. The ridgesof the tissue retention feature may also be in the shape of a threadedscrew or other shape suitable to prevent the plug 2 from being easilyremoved from a surgical portal once the plug 2 is disposed within asurgical portal. The distal end of the sheath is provided with arounded, arcuate or frustoconial shaped tip.

FIG. 4 illustrates the inner core 9 for use in conjunction the portalplug 2. The inner core 9 comprises a rigid shaft 23 having one or moregrooves, channels or flutes 24 disposed longitudinally along the core'souter surface. The core is provided with a frustaconical or arcuateshaped tip 25 disposed on its distal end. A finger grip 26 or handle isdisposed on the proximal portion of the inner core and may be integrallyformed with the inner core. The inner core 9 may also be provided with acenter lumen 27 allowing the core to drain fluid from a surgical site.

FIG. 5 shows a radial cross-sectional view of portal plug 2 with theinner core 9 using the inner surface of the sheath wall with the outersurface of the inner core to form drainage lumens. The inner surface 28of the wall of the sheath and the outer surface 29 of the inner coreforms a seal and the side walls 30,31 and bottom walls 32 of the flutes24 and the wall of the tube create the longitudinal drainage lumens 33,34, 35 and 36. One or more drainage apertures 21 are disposed on theouter surface of the body or central portion 15 of the sheath. Thedrainage apertures are in fluid communication with the one or moredrainage lumens 33, 34, 35 and 36. The drainage lumens 33, 34, 35 and 36and run longitudinally along the sheath and are sized and dimensioned toaccommodate fluid outflow from tissue surrounding a surgical site. Thesize of the drainage apertures can be used to control the percolationrate of the sheath 8.

When the portal plug 2 is in use, inner core 9 containing longitudinalgrooves is disposed in the central lumen 10 of the sheath. The core 9may or may not be covered by a secondary protective sheath prior toinsertion. Once inserted, the outer surface 29 of the core frictionallyengages the inner surface 28 of the sheath. The force of the outersurface 29 of the core pushes against the inner surface of the sheath.Outer drainage lumens 33, 34, 35 and 36 are created by the flutes 24 andthe inner surface of the outer wall of the sheath. The seals formed bythe contact between the sheath and the outer surface of the core preventfluids from flowing between the outer drainage lumens 33, 34, 35 and 36.The outer drainage lumens 33, 34, 35 and 36 facilitate the outflow offluids from tissue surrounding a surgical site through the drainageapertures in the central portion of the sheath. When a user wants tostop or reduce the outflow of fluid from an open surgical portal not inuse by another surgical instrument, the user inserts the portal plug 2into the surgical portal. The portal plug is placed in fluidcommunication with tissue surrounding the surgical field through thedrainage apertures 21 in the sheath. The outflow of fluid is regulatedor stopped by rotating the inner core within the sheath as shown in FIG.6. This reduces or eliminates the amount of drainage lumens placed influid communication with the drainage apertures.

The drainage of fluid from tissue may also be regulated by using aportal plug with an alternative method of control. FIG. 7 illustratesthe sheath 8 or close-end tube of FIG. 2 having a control valve disposedon its proximal end. In FIG. 7, a valve 41 or other fluid control meansis disposed on the proximal section of the sheath 8. The valve 41 isplaced in fluid communication with the sheath's central lumen 10 and adrainage port 42. The drainage port 42 is operably coupled to a vacuumsource or sink to actively or passively facilitate fluid removal.

FIG. 8 shows the sheath 8 of FIGS. 2 and 3 having a membrane valve 43 orseal disposed in its distal end 11. The wall 44 of the sheath on thedistal end creates a fluid resistant seal that seals against fluidpressure but allows passage of arthroscopic surgical instruments 45 usedin the arthroscopic procedures. The wall comprises self-sealing siliconecapable of accommodating the surgical instrument by resilientlyexpanding and conforming around the surgical instrument when thesurgical instrument is forced through the bottom wall and resilientlyclosing to a fluid tight seal when the surgical instruments are removed.Thus, the bottom wall or fluid resistant seal allows for insertion ofvarious instruments, catheters and elongate medical devices whilefunctioning as a membrane seal that minimizes fluid leakage. The bottomwall may also be provided with a slit (single or cross-cut) tofacilitate insertion and removal of the surgical instruments or othermedical instruments.

FIG. 9 illustrates an alternative embodiment of a surgical portal plug46 while FIG. 10 illustrates a longitudinal cross-section of thesurgical portal plug 46. Here, the plug 46 comprises a frustoconicalbody 47 having a coaxial central lumen 48. The central lumen 48comprises blind hole or bore that stops proximal to distal end of thefrustoconical body. Drainage lumens 49 extend radially outward from thecenter lumen placing the center lumen in fluid communication withdrainage apertures 50 disposed along the central portion 51 of the plug.The drainage apertures are disposed in such a way that they are placedin fluid communication with tissue surrounding a joint capsule orsurgical field when the plug is in use. The drainage apertures 50communicate with one or more drainage lumens 49 disposed inside theplug, thereby allowing fluid to drain from the tissue surrounding thejoint capsule to sources or sinks located outside the patient through adrainage port in fluid communication with the central lumen 48 disposedon the proximal section of the plug. A cylindrical shaped finger grip 52extends proximally from the proximal section of the frustoconical bodyand can be operably coupled to a vacuum source.

The outer surface of the proximal section of the plug is corrugated orprovided with ridges 53 to prevent the sheath or instrument from beingunintentionally forced out of the operating field. The ridges of thetissue retention feature are circumferentially disposed around the plugand may be in the shape of straight ridges extending radially outward asillustrated in FIG. 10. The ridges of the tissue retention feature mayalso be in the shape of a threaded screw or other shape suitable toprevent the plug from being easily removed from a surgical portal oncethe plug is disposed within a surgical portal. The integrally structuredsurgical plug 2 may be manufactured from biocompatible polymers such assilicone.

The portal plug 2 can be part of a complete fluid management systemcomprising a fluid source, vacuum source, arthroscopic surgical pump andcontrol system. An over pressure valve can be operably coupled to theplug to allow a drainage lumen in the device to open and drain the jointif the joint is over-pressurized by an arthroscopic pump.

FIG. 11 illustrates the anti-extravasation surgical portal plug having asheath 8 with a retention system. The outer surface of the sheath 8shown in FIGS. 2 through 8 may further comprise a retention system 54having a plurality of atraumatic retention features including cup-shapeddepressions, bellow-shaped extensions, concave pockets or a series ofridges. The retention system may be embossed in the outer surface of thesheath or the retention system may comprise separate devices coupled tothe outer surface of the sheath. The retention system 54 is sized anddimensioned to function as a plurality of suction-cups and has roundedatraumatic edges. When the sheath 8 with the retention system 54 is inuse, tissue is drawn to the outer surface of the sheath 8 by thedrainage apertures 21. A partial vacuum is produced when the retentionfeatures of the retention system disposed on the outer surface of thesheath come in contact with tissue surrounding the surgical portal. Thetissue retention system 54 may be disposed on our otheranti-extravasation devices such as those disclosed in our U.S. patentapplication Ser. No. 11/335,077, filed Jan. 18, 2006 and U.S. patentapplication Ser. No. 11/346,764, filed Feb. 3, 2006 both of whichapplications are fully incorporated in their entirety by reference. Thevacuum produced by the retention features prevents the sheath from beingeasily removed from the surgical portal while preventing the additionaltrauma induced by traditional retention features.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the inventions. Otherembodiments and configurations may be devised without departing from thespirit of the inventions and the scope of the appended claims.

I claim:
 1. A surgical portal plug comprising: a close-ended tubecharacterized by a distal portion, a central portion, a proximal portionand a central lumen, said central lumen terminating proximal to thedistal end of the tube; a plurality of drainage apertures disposed onthe central portion of the tube on the tube outer surface; a pluralityof drainage lumens disposed on the central portion of the close-endedtube in fluid communication with the central lumen and the drainageapertures, said drainage lumens extending radially outward from thecentral lumen; and a retention system disposed about an outer surface ofthe tube, said retention system sized and dimensioned to create a vacuumwhen tissue surrounding the surgical portal comes in contact with thesystem.
 2. The portal plug of claim 1 wherein the retention systemcomprises a plurality of retention features selected from the groupconsisting of cup-shaped depressions, bellow-shaped extensions, concavepockets and a series ridges.
 3. The portal plug of claim 1 wherein theretention system is embossed in the outer surface of the tube.
 4. Theportal plug of claim 1 wherein the retention system comprises separatedevices coupled to the outer surface of the tube.